Home NDC 60687-423 Clobazam
Product NDC 60687-423
11-digit product format 606870423
Labeler code 60687
Product ID 60687-423_3d5d1f23-c639-3604-e063-6294a90ac606
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clobazam
Dosage form TABLET
Route ORAL
Labeler American Health Packaging
Application ANDA209718
Marketing category ANDA
Marketing start 2019-01-17
Substance CLOBAZAM
Active strength 10 mg/1
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209718-001 CLOBAZAM CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 A209718-002 CLOBAZAM CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209718-001 CLOBAZAM 10MG TABLET / ORAL AB 2018-10-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A209718-002 CLOBAZAM 20MG TABLET / ORAL AB 2018-10-22 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clobazam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOBAZAM 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2MRO291B4U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199450 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60687-423-11 Clobazam 1 in 1 BLISTER PACK TABLET 1 9 60687-423-21 Clobazam 30 in 1 BOX, UNIT-DOSE TABLET 30 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-423 CLOBAZAM TABLET [AMERICAN HEALTH PACKAGING] 8 Current NDC, Legacy NDC, 2 package rows 20241013_8fce3252-95f8-4428-9922-5ba308e20177.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60687-423-11 60687042311 1 in 1 BLISTER PACK Historical 60687-423-21 60687042321 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-423-21) / 1 TABLET in 1 BLISTER PACK (60687-423-11) 30 blister pack 2019-01-17 0000-00-00 No No Current